N/A
N=10,003
PROspective Multicenter Imaging Study for Evaluation of Chest Pain
Chest Pain
Bottom Line
View on ClinicalTrials.gov: NCT01174550 ↗Enrolled (actual)
10,003
Serious AEs
3.3%
Results posted
Feb 2016
Primary outcome: Primary: Time to Primary Endpoint — 1.0; 1.1; 1.2; 1.4 Percentage of participants with an event
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coronary Angiography (Procedure); Stress Echocardiogram (Procedure); Nuclear Stress Test (Procedure); Exercise Electrocardiogram (Procedure)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Primary Endpoint |
1.0; 1.1; 1.2; 1.4; 1.8; 1.9 | — |
| SECONDARY Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization |
0.9; 1.0; 1.2; 1.4; 1.8; 1.9 | — |
| SECONDARY Time to Death or Myocardial Infarction (MI) |
0.3; 0.6; 0.4; 0.9; 0.8; 1.2 | — |
| SECONDARY Time to Major Complications From Cardiovascular (CV) Procedures |
0.1; 0.3; 0.2; 0.5; 0.5; 0.8 | — |
| SECONDARY Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) |
4.4; 5.2; 4.6; 5.6; 5.2; 6.1 | — |
| SECONDARY Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization |
3.4; 4.3 | — |
| SECONDARY Medical Cost |
2494; 2240; 7213; 6586 | — |
| SECONDARY Quality of Life (QOL) as Measured by Duke Activity Status Index |
21.5; 22.9; 30.5; 30.2; 29.2; 31.2 | — |
| SECONDARY Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale |
70; 80; 100; 100; 100; 100 | — |
| SECONDARY Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale |
58.3; 58.3; 83.3; 83.3; 83.3; 91.7 | — |
| SECONDARY Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing |
43.3; 46.5; 47.3; 48.8; 52.1; 54.3 | — |
| SECONDARY Cumulative Radiation Exposure Within 90 Days |
10.0; 11.3 | — |
Summary
A prospective multicenter imaging study for evaluation of chest pain. Objective is to determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). Study hypothesis: initial anatomic testing strategy will provide information that will result in superior long-term health outcomes as compared to an initial functional testing strategy.
Eligibility Criteria
Inclusion Criteria
- new or worsening chest pain suspicious for clinically significant coronary artery disease (CAD)
- no prior evaluation for this episode of symptoms
- planned non-invasive testing for diagnosis
- men age ≥55 years
- men age ≥45 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than 50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms
- Contraindication to undergoing a coronary tomographic angiography (CTA), including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers unless heart rate < 65 beats per minute, c. Pregnancy
- Life expectancy < 2 years
- Unable to provide written informed consent or participate in long-term follow-up
Data sourced from ClinicalTrials.gov (NCT01174550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.